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PT003 MDI Dose Confirmation Study

NCT01349816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2017-04-27

Study results available
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Summary

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

PT003

PT003 MDI administered as two puffs BID for 7 days

DRUG

PT001

PT001 MDI administered as two puffs BID for 7 days

DRUG

PT005

PT005 MDI administered as two puffs BID for 7 days

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner, M.D. · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349816 on ClinicalTrials.gov